Analytical Scientist (Anti Body Drug Conjugates)
- Veranova L P
- Devens, Massachusetts
- Full Time
Who We Are:
At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.
Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.
Role Overview:
We are seeking a highly motivated and skilled Analytical Scientist with experience in analyzing antibody drug conjugates (ADC) to join our Analytical team in New England. The successful candidate will play a hands-on role in the development, qualification, transfer, and validation of analytical methods to support the development of ADC’s and other complex bioconjugates.
Core Responsibilities:
- Exercise technical judgment in the planning, implementation, and analysis of experiments related to method development, validation, reference standard creation and qualification, forced degradation, product characterization, and compatibility studies in accordance with pertinent ICH regulatory guidelines.
- Perform method development, characterization, validation and analysis of bioconjugates including DAR (drug antibody ratio), DAR conjugation site occupancy, charge and size variants, purity, potency, free antibody and free linker payload using techniques such as HPLC, mass spectrometry, icIEF, SEC, CE-SDS, ELISA, Western Blot and UV-VIS spectrophotometry.
- Author test methods, protocols, reports, and regulatory documents as needed.
- Provide support for development and cGMP manufacturing campaigns, ensuring compliance with regulatory requirements and documentation standards - including both in-process and release samples.
- Adhere to safety and quality standards.
- Communicate technical findings and results to both internal and external stakeholders, including clients and regulatory bodies.
- Well organized with good problem-solving skills, a high level of attention to detail and have a passion for delivering high quality data in a fast-paced environment.
- Collaborate with chemistry development scientists, quality control and regulatory affairs teams to ensure successful project delivery.
- Mentor and develop scientific staff. Ensure continued technical and professional growth of department members, encourage efforts towards excellence and knowledge sharing.
- Possess strong communication (oral, written), organizational, and leadership skills.
Qualifications:
Required
- Ph.D., M.S., or B.S. in Analytical Chemistry, Biochemistry, Chemistry, Chemical/Biomedical Engineering, or other related scientific discipline with relevant experience in analytical method development, validation and characterization of bioconjugates.
- PhD with 4+ years of experience in a GMP environment or MS with 8+ years of experience in a GMP environment or BS with 10 + years of experience in GMP environment.
- Hands on experience with various techniques used in the characterization of ADC’s such as HPLC, mass spectrometry, icIEF, SEC, CE-SDS, Western Blot, UV-VIS spectrophotometry, etc.
- Familiarity with cGMP, GLP, and regulatory guidelines for bioconjugate development.
- Demonstrates good judgment, decision-making skills, and the ability to work both independently and in a team environment.
- Skilled in technical writing.
- Experience in mentoring staff in analytical department.
- Strong communication and teamwork skills in a cross-functional environment.
Our Commitment:
- Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
- Financial Wellness: Comprehensive total compensation package that includes competitive base salary, Defined Contribution Pension program, eligibility for performance-based bonuses, and attractive 401(k) Plan with company match.
- Professional Development : Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
- Inclusive Culture : At Veranova an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.
How to Apply:
At Veranova, we are on a mission to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit www.veranova.com to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise.
We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed.
If you are a veteran, first responder, or in the process of transitioning from service member to civilian life, we encourage you to apply. Your experience brings invaluable skills and insights that can contribute to our team.
For applicants who may require a reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to ... in order to confirm your request for an accommodation. Please include the job number, title, and location of role. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Veranova employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Additional Information:
Applicants for this role must be authorized to work in the United States without further employer sponsorship.
Agency and Search Firm Representatives : Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.
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Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
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